COVID-19 vaccine hesitance is often tied to education level The Indianapolis Star
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COVID-19 vaccine hesitance is often tied to education level - The Indianapolis Star
For Immediate Release: August 23, 2021
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Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
The FDAs approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDAs rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product, said Acting FDA Commissioner Janet Woodcock, M.D. While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Todays milestone puts us one step closer to altering the course of this pandemic in the U.S.
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
FDA-approved vaccines undergo the agencys standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturers submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDAs standards for approval.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individuals genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnatys safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities, said Peter Marks, M.D., Ph.D., director of FDAs Center for Biologics Evaluation and Research. We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDAs approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDAs review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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A limited set of exemptions will be approved on a case-by-case basis. Details about the online exemption process will be shared in the coming days
Health-related
An individual can request a health-related exemption through submission of appropriate documentation from their treating health care provider. Any health-related exemptions will be reviewed on a case-by-case basis by Employee Health and Student Health Services.
In addition, those with a history of allergic reactions to other vaccines or medical injections will be considered for exemptions on a case-by-case basis with appropriate documentation of the allergic reaction provided by the individuals treating health care provider.
Individuals with a history of either a documented COVID-19 infection or a history of having received a COVID-19 monoclonal antibody infusion within 90 days prior to the deadline will be eligible for a temporary exemption until after the end of the 90-day period. The individual will then be required to receive a COVID-19 vaccination within 14 days of the end of the exemption.
Personal or Religious
An exemption based on an individuals religious beliefs or practices or based on personal reasons can be requested. Employees must submit a request for religious and personal exemptions. As part of the request, the employee must attest to their reason for exemption and explanation. All religious and personal exemptions will be reviewed by Employee Relations in conjunction with Employee Health.
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All Aurora Public School employees will be required to get a COVID-19 vaccination now that the U.S. Food and Drug Administration fully approved the Pfizer one this week, district officials said Monday.
Superintendent Rico Munn wrote in May and again this monththat the approval would be the tipping point for requiring vaccinations for the entire districts staff. Moderna and Johnson & Johnsons shots have not received the same approval as Pfizer.
The most significant layer to prevent transmission of COVID-19 is for as many people in the APS community to receive the COVID-19 vaccines as possible, Munn wrote Friday.
Then Damon Smith, the districts chief personnel officer, emailed employees Monday noting the FDAs approval and telling staff they must be fully vaccinated by Oct. 7. Those who fail to get the vaccine will face discipline including suspension, leave without pay and possibly termination.
Employees who legitimately cannot be vaccinated will be required to wear masks, socially distance from others and take periodic tests for the virus, Smith wrote.
The district has about 38,000 students and about 6,000 employees, some 2,100 of which are teachers.
The district will join Denver Public Schools in requiring faculty and staff to be vaccinated.
Adams Countys Board of Commissioners headed a different direction Tuesday, following in Douglas County commissioners footsteps by voting 3-2 to opt out of Tri-County Health Departments order requiring masks for children between the ages of 2 and 11, county representative Christa Bruning said in a release.
Adams County said the vote was meant to allow each school district to follow current requirements or create their own.
County Commissioner Eva Henry called Tri-Countys mandate flawed in the release and said local school boards and the Colorado State Board of Education is in the best position to decide what to require for students and their communities.
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Aurora Public Schools employees will be required to get COVID-19 vaccine - The Denver Post
Boise, Idaho Governor Brad Little addressed the people of Idaho today in a video message regarding the positive news that the U.S. Food and Drug Administration (FDA) announced its full approval of the first COVID-19 vaccine.
View the Governors video message at this link: https://www.youtube.com/watch?v=RlguYAaeoro
Governor Littles full message to the people of Idaho follows:
The United States of America reached a significant milestone today the FDA announced it fully approved the first COVID-19 vaccine.
Close to 800,000 Idahoans and more than 200 million Americans have received the COVID-19 vaccine safely, and the FDA full approval for the Pfizer vaccine helps impart additional confidence for Idahoans still on the fence about getting the shot.
Experts in science and medicine rigorously evaluated the safety of the vaccine in accordance with very high standards.
President Donald Trump last year boldly moved our country forward with Operation Warp Speed the first-ever public-private partnership of its kind to enable faster approval and production of COVID-19 vaccines during the global pandemic.
Today, we reached the culmination of President Trumps leadership.
It is a proud moment in our nations history.
America is the best country in the world. We are able to offer our citizens a free, convenient, life-saving vaccine. Many people across the globe are not as fortunate.
To our friends and neighbors still waiting to receive the vaccine, the time to get the shot is NOW.
By getting the shot now, you can protect yourself and others and ensure healthcare access remains available for everyone.
By getting the shot now, you can ensure a strong, healthy workforce and continued economic prosperity in our state.
And, importantly, by getting the shot now, you can ensure our students have a productive, successful school year.
Thank you and God Bless.
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SEATTLE The University of Washington (UW) in Seattle will no longer allow students or personnel to claim a philosophical exemption to getting the COVID-19 vaccine.
Individuals who claimed a philosophical exemption will be contacted in the near future, UW said.
Inslee's mandate requires state employees, health care workers, K-12 school employees and those in higher education to be fully vaccinated against COVID-19 by Oct. 18 or face losing their jobs.
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University of Washington ends philosophical exemptions for COVID-19 vaccine - KING5.com
On Monday, the New England Patriots announced a problem with quarterback Cam Newton. Newton, who the team announced traveled to a Club-approved medical appointment that required him to leave the New England area, was forced into a reentry process due to a misunderstanding about Covid-19 tests.
The problem however, could have easily been avoided if Newton was fully vaccinated - as only those who are not vaccinated must enter the five-day reentry process. Instead, Newton is now sidelined for four days of practice, including the first of two joint practices against the New York Giants.
Meanwhile, the problem has become a major story line in the dog days of training camp. On Tuesday, veteran Matthew Slater provided his insight on the vaccination issue and how a players choice could negatively affect the team.
I think weve already had those conversations leading up to this point, Slater said Tuesday. I dont like the idea of trying to force someone to do something like that, especially when it comes to their health, their body. I dont like the idea of, Hey, youve gotta do this because I said youve gotta do it.
Obviously when youre dealing with grown men, they dont respond well to that sort of thing. So, we had those conversations. Guys are doing what they think is best for them. We have to respect that, and well see how this thing plays itself out. Obviously, we want everyone to stay safe and healthy. We want our football team to be healthy and productive. Were just going to have to take that one day at a time.
Long time captains Slater and McCourty whose wives are both doctors recorded a Patriots-produced PSA earlier this offseason, providing educational information on vaccines:
Look, this is an issue that is obviously a tough one for our community within the football realm but also nationally and worldwide. For me, its just about guys getting educated, Slater answered when asked about the videos message.
Ultimately, I truly believe everyone has a choice to make, and they have to do whats best for them. They have to take the advice of their healthcare providers, their family, their medical history, and make a decision thats best for them.
So, we obviously say that in the video, but I think its good for people to educate themselves. Theres a lot of misinformation out there. If you dont know, ask questions, try to get educated, and then make a decision thats best for you. Im not going to sit here and bang the drum one way or another because I do believe its a personal choice.
When asked about Newton and the vaccination rules Tuesday morning, head coach Bill Belichick did not have anything to add onto in regards of the statement the team released.
The league rules are the league rules, Belichick said. Well be compliant with them. Whatever they are, they are. Every team is dealing with the same situation.
According to NFL Networks Mike Giardi, there has been a level of frustration from the organization with Newtons current situation, and the mistake could have potentially opened a window of opportunity for rookie Mac Jones.
Make sure to follow Brian on Twitter @iambrianhines!
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Matthew Slater shares his thoughts on Covid-19 vaccination in the NFL - Pats Pulpit
TOPEKA, (KSNT) With the Pfizer vaccine fully approved by the FDA, some parents may be wondering whether schools will soon require coronavirus vaccinations for students and staff.
In Kansas, the potential of that happening for public K-12 schools and universities doesnt seem likely at the moment.
A spokesperson for the State Board of Education told Kansas Capitol Bureau on Tuesday that they are not aware of any districts having vaccine mandates at this time.
The same goes for some higher education officials in the state. A representative for Pittsburgh State University said the school has no current plans to change vaccine requirements, pointing to a bill passed earlier this year.
The provision in the most recent Kansas budget bill signed by Governor Kelly banning vaccine passports prohibits Pitt State from enforcing a vaccine mandate on our campus. We will carefully watch this throughout the next legislative session, as we do believe in the effectiveness of vaccines in curbing the spread of the virus.
The same goes for Kansas State University, whose spokesperson said the legislation passed in May prohibits the university from requiring students, faculty, and staff to get the coronavirus vaccine.
Other universities that have confirmed with Kansas Capitol Bureau that they have not made plans to require the vaccine, include Washburn University, Emporia State University, and Fort Hays State University.
While some schools may not be changing requirements, there is a strong push to do whats necessary to keep students safe, especially as cases increase and the highly contagious Delta variant spreads.
Marcus Baltzell, a spokesperson for the Kansas National Education Association, said its important for people to get vaccinated, and use proven safety measures to keep students and teachers in the classroom.
Masking, social distancing, hygiene, all of those things work, he said.
According to the CDC, as of Tuesday, 47.4 % of the state has been fully vaccinated.
This comes as hospitalizations are reaching new heights. Cindy Samuelson, a spokesperson for the Kansas Hospital Association, said daily and weekly reports are showing that hospitals are seeing an increasing amount of younger patients coming in.
We are seeing an average age thats younger than weve ever seen before, related to COVID patients, she said.
State health officials and state leaders said there are concerns for students, especially those younger than 12, who arent currently eligible to get the vaccine. Thats why some public school advocates, like Baltzell, said its important for people who can get vaccinated, to get it now.
We want everybody to pull together and to do everything they can, to avoid the individual impact to kids. That means kids can stay in classrooms, with their educators for the long-term.
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Kansas public schools & universities are not requiring COVID-19 vaccines; Heres why - KSNT News
A healthcare worker in the Netherlands is given the Pfizer-BioNTech vaccine on January 6. Piroschka van de Wouw/Pool via AP
Fully vaccinated people who get COVID-19 may be less infectious than unvaccinated people, a study suggests.
Scientists looked at 161 "breakthrough" infections in 24,706 health workers, mostly caused by Delta.
Vaccinated people cleared the virus quicker than unvaccinated people, they said.
See more stories on Insider's business page.
Fully vaccinated people who catch the Delta variant appear to be less infectious than unvaccinated people who have COVID-19, early research suggests.
A Dutch study led by scientists at Rotterdam's Erasmus Medical Center also found that fully vaccinated people who caught the Delta variant got rid of the virus faster than unvaccinated people who caught a less infectious strain.
Particles of the virus in vaccinated people's noses and throats were less likely to be infectious than in unvaccinated people, the study authors said.
This was despite both groups initially carrying a similar level of virus, the researchers said.
The research adds to a growing body of evidence that vaccines help slow the spread of the Delta variant beyond simply stopping infection. In theory, if you're less infectious for less time, you're less likely to pass on the virus. A multi-centre study from Singapore, posted on July 31, reported similar results.
But there's more work to be done before we can draw firm conclusions on how vaccines impact transmission.
Data shows that vaccines work against the Delta variant, and that "breakthrough infections" - i.e., when a vaccinated person gets COVID-19 - are usually mild.
In the Dutch study, researchers examined the COVID-19 lab tests of 161 breakthrough infections in 24,706 fully-vaccinated health workers between April and July. Delta caused most of the infections.
Roughly 85% of the 161 breakthrough infections were symptomatic, but none required hospital admission, the researchers said.
More than half of those in the vaccinated group, which had an average age of 25, had received Moderna's shot, but the authors said findings were similar in people vaccinated with the Pfizer, AstraZeneca, or Johnson & Johnson COVID-19 vaccines.
Story continues
Delta became dominant after most health workers in the country were vaccinated, so for the control group, researchers tested unvaccinated people who caught a less infectious virus strain between April and December 2020.
Read more: Experts explain why the mRNA tech that revolutionized COVID-19 vaccines could be the answer to incurable diseases, heart attacks, and even snake bites: 'The possibilities are endless'
Both the Singapore and Dutch studies measured the number of virus particles, which is considered the best proxy for how infectious somebody is - but it's an imperfect measure that varies from person to person and throughout the course of illness.
Neither study has been scrutinized by other experts in a peer review.
The Dutch scientists cautioned that infectious virus particles were found in 68.6% of breakthrough cases.
The "infectivity of individuals with breakthrough infections should not be neglected," they said.
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The University of Iowas Hospitals and Clinics are currently participating in three COVID-19 vaccine trials that are all at different stages.
Jeff Sigmund
A medical student receives their Moderna vaccine along with other University of Iowa students on Thursday, Jan. 28, 2021.
After over a year of participating in COVID-19 vaccination trials for various pharmaceutical companies, the University of Iowa Hospitals and Clinics is contributing to a vaccine booster study among other vaccine research to provide more knowledge and data.
UI Carver College of Medicine Executive Dean Patricia Winokur, who oversees vaccine trials at UIHC, said the university is very proud of its contribution to these historic trials.
To be part of the knowledge base that has brought a trial and to begin within a year is due a moment of pride, I think, for all of us here at the University of Iowa, she said. On a more practical side, I think it was an opportunity for us to learn firsthand about how well these vaccines were tolerated and to understand how comprehensive the follow-up was.
Winokur said this helps her and others involved in the trials mitigate concerns from the community about the vaccine since she saw the work first-hand.
UIHC has been involved with the Pfizer COVID-19 vaccine trials since summer 2020, when Cedar Rapids City Councilor Ashley Vanorny joined as a participant. Vanorny enrolled in the and received either a placebo shot or a shot with a booster dose on Aug. 6, 2021.
While she doesnt know which she received, she said, she is currently in the same position as people who are not participating in the trial and is excited to see what happens next.
Im just waiting, like everybody else, at this point in time to see how the science comes out, to see what gets approved through the FDA, she said. And if I received the placebo, then I would get caught up with that third shot.
RELATED: Local and state health officials urge Iowans to get vaccinated as Delta variant gains strength
Vanorny started as one of 270 participants in the Iowa City area. Winokur said 80 of the initial participants were selected for the booster shot trial. She said that trials should be wrapping up soon.
The data is accumulating, she said. That tells us we need to consider boosters.
The Food and Drug Administration approved booster doses for immunocompromised people on Aug. 13. Last week, federal health officials strongly recommended everyone get a booster shot eight months after their initial shots, and recent Centers for Disease Control and Prevention studies suggested vaccine effectiveness may wane over time.
The two-shot COVID-19 vaccine from Pfizer is currently looking to receive full approval from the FDA. Vanorny said she is staying vigilant as a participant in the trials, as guidance or information can change daily regarding the vaccines.
Some of this can be confusing and frustrating, she said. Certainly as the science changes, as the circumstances change, so do the mitigation strategies Its really important for us not to get frustrated, to realize that the health care community is trying to get the best information out as soon as they have it, so that means information may change.
As a participant, Vanorny keeps a digital diary on an app to log potential symptoms. She said the only difference between the initial trial and the booster shot one is that she had to re-login to the app to continue documenting her experience.
Alongside Pfizer, Winokur said UIHC is participating in trials for the Novavax vaccine, and recently put out a call for participants in a trial for Sanofis vaccine.
Since most people who want to be vaccinated already are, she said it is becoming difficult to find participants for new trials.
Winokur said the Novavax trials are in follow-up currently, and UIHC is pushing the company to begin a booster shot study.
The Sanofi trial is looking to use messenger RNA in a different way than other vaccines, she said. Both Pfizer and Modernas vaccines use messenger RNA.
They are trying to get studies of a new messenger RNA platform, using COVID-19, she said. I think these platforms are here to stay. Theyve been very successful.
Winokur said she knows the Pfizer vaccine process did not skip any steps and wasnt rushed something shes heard as an excuse for why people dont want to get the vaccine.
However, Johnson County is the most vaccinated county in Iowa, which Winokur attributes to UIHCs participation in various trials.
I absolutely think that [the trials] has been one of the reasons our vaccination rates are higher in Johnson County than in some of the other counties, she said. I think our marketing and communications team has worked very hard to keep people updated and having that practical experience and being able to deliver that to the public has been very helpful.
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UIHC participates in various COVID-19 vaccine trials - UI The Daily Iowan
